A hernia occurs when part of an internal organ, most often the intestines, protrudes through an abnormal opening or weakening in the wall surrounding the abdominal cavity.
There are four main types of abdominal hernias: (1) Inguinal Hernia—a bulge in the groin; (2) Femoral or Ventral Hernia—a bulge in the groin that appears between the navel and the breastbone; (3) Umbilical Hernia (newborn-related or paraumbilical hernia)—a bulge in the navel area; and (4) Incisional Hernia—a bulge in the stomach and navel area that is usually caused by a prior surgical incision in the area. A hernia is called reducible if the bulge can be manipulated back into place inside the abdomen. A hernia is called irreducible or incarcerated when the hernia cannot be reduced, e.g., because adhesions have formed in the internal sac. A hernia is characterized as strangulated if part of the herniated intestine becomes twisted or edematous (swollen), causing serious complications.
Hernia repairs are sometimes subdivided into two classes, laparoscopic repair and open repair, both of which are accomplished by strengthening the defect with a synthetic hernia mesh. In the case of open repair, an incision is made in the vicinity of the defect to expose the defect area such that the hernia mesh can be attached to surrounding tissue (e.g., with sutures and/or tacks). In the case of laparoscopic repair, instruments and internal cameras specially designed for the intricate procedure make minimally invasive internal repair possible. Laparoscopic repair typically involves inserting the hernia mesh into the abdominal cavity through a small instrument port (sometimes referred to as an access cannula or a trocar) and then attaching the hernia mesh to the distal side of the defect with sutures and/or tacks, whereby to strengthen the defect. This type of hernia repair typically results in less pain for the patient and faster recovery times.
Fixation of the hernia mesh over the defect is required for both open repair and laparoscopic repair in order to avoid postoperative migration of the hernia mesh. Fixation of the hernia mesh to the abdominal wall is generally accomplished using sutures and/or tacks.
Currently, single-needle suture passers are generally used to pass sutures through the abdominal wall and the hernia mesh. These single-needle suture passers typically comprise a hook-and-clasp piercing tip that releasably secures the suture to the needle with a clasping detail that opens as the hook-and-clasp piercing tip is extended distally from the needle and closes when the hook-and-clasp piercing tip is withdrawn back into the needle. See FIGS. 1 and 2.
For each suture (typically referred to as a “securing suture”), the abdominal cavity is pierced twice: (1) the first time at a first location to pass (antegrade) a first end of a securing suture from outside the body, through the abdominal wall, through the hernia mesh, and then release the first end of the securing suture within the abdominal cavity; and (2) the second time at a second, laterally-spaced location to retrieve the first end of the securing suture and to pass it (retrograde) back through the hernia mesh and abdominal wall to a point outside the body. By laterally spacing the location of the second needle penetration from the location of the first needle penetration, a portion of the securing suture will extend along a portion of the hernia mesh so as to securely engage the hernia mesh. The surgeon then ties the first end of the securing suture to a second end of the securing suture, thereby securing the hernia mesh to the abdominal wall.
In some cases the hernia mesh may be “pre-equipped” with one or more “positioning sutures”, wherein the positioning sutures have been secured to the hernia mesh prior to the hernia mesh being inserted into the abdominal cavity. In this situation, after the hernia mesh has been positioned inside the abdominal cavity, a single-needle suture passer is passed (antegrade) from the region outside the body through the abdominal wall and through the hernia mesh, then the suture passer is used to grasp the free end of the positioning suture (see FIGS. 3 and 4) and pull it back through the hernia mesh and the abdominal wall, so that the surgeon may thereafter use the positioning suture to hold the hernia mesh in position against the abdominal wall while securing sutures are set and tied down in the manner previously described.
Improvements are needed to eliminate the time required for the aforementioned double-piercing operation when setting securing sutures using single-needle suture passers, and for ensuring the accurate placement of the first and second needle penetrations by the single-needle suture passers so as to facilitate proper positioning of the securing sutures. These improvements include the use of a twin-needle, single-penetration approach that employs a twin-needle suture passer having a first needle to pass the securing suture into the abdominal cavity and a second needle to retrieve the securing suture from the abdominal cavity. However, the twin-needle suture passers developed to date tend to suffer from a variety of limitations.
To be more broadly accepted, (i) the twin needles should enter the abdominal cavity through a small (e.g., 3 mm) incision and then controlled to open to a larger spread (e.g., 10 mm) as the needles pass through the hernia mesh; (ii) the device should be easily reloaded with multiple securing sutures throughout the procedure; (iii) the device should be easily adaptable from a twin-needle suture passer for deploying multiple securing sutures to a single-needle suture retriever for grasping the loose ends of positioning sutures and pulling them back through the hernia mesh and the abdominal wall; and (iv) the device should include an added safety feature to cover the sharp tips of the needles until the sharp tips are disposed in the abdomen, whereby to protect medical personnel as the device is passed to and from the surgeon.